Emergent BioSolutions Files Investigational New Drug Application With FDA for Pivotal Anthrax Immune Globulin Clinical Trial

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the company’s Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic treatment for patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body. Pending the standard 30-day FDA review period, the company expects to initiate a pivotal clinical trial in 2007 in order to evaluate AIG safety and pharmacokinetics in 105 healthy volunteers

MORE ON THIS TOPIC